Standard Operating Procedure for Air Filtration System in Ocular Dosage Form Manufacturing

1) Purpose

The purpose of this SOP is to establish procedures for the operation and maintenance of the air filtration system in the manufacturing of ocular dosage forms to ensure a controlled and clean environment, free from airborne contaminants.

2) Scope

This SOP applies to all air filtration systems within the facility that are used to maintain air quality in cleanrooms and controlled environments where ocular dosage forms are manufactured.

3) Responsibilities

Facility management and maintenance personnel are responsible for the operation, maintenance, and monitoring of the air filtration system. Quality assurance personnel are responsible for overseeing compliance with regulatory requirements and standards.

4) Procedure

4.1 Start-up and Shutdown Procedures

1. Ensure all personnel are trained on start-up and shutdown procedures for the air filtration system.
2. Check and verify power supply to the air filtration unit before starting.
3. Follow manufacturer’s instructions for starting up and shutting down the system.

4.2 Routine Operation

1. Monitor and record operating parameters such as airflow rate, pressure differentials, and filter status regularly.
2. Adjust airflow rates as necessary to maintain specified cleanliness levels in cleanrooms.
3. Monitor alarm systems and respond promptly to any deviations or abnormalities.

4.3 Filter Replacement and Maintenance

1. Schedule routine filter replacements based on manufacturer’s recommendations and facility-specific requirements.
2. Verify filter integrity and seal before installation.
3. Dispose of used filters according to facility waste management procedures.

4.4 Cleaning and Sanitization

1. Clean air intake vents and external surfaces of the air filtration unit regularly using approved cleaning agents and methods.
2. Sanitize internal components of the filtration unit as per validated procedures to prevent microbial growth.

4.5 Emergency Procedures

1. Develop and maintain emergency procedures for power failures, equipment malfunctions, or other emergencies affecting the air filtration system.
2. Train personnel on emergency response procedures and ensure availability of backup systems or contingency plans.

4.6 Calibration and Validation

1. Calibrate monitoring instruments used to measure airflow, pressure differentials, and other critical parameters.
2. Validate the performance of the air filtration system periodically according to regulatory requirements and industry standards.

4.7 Documentation and Records

1. Maintain records of routine operations, maintenance activities, filter replacements, and validation results.
2. Document any deviations from standard procedures and corrective actions taken.

4.8 Training

1. Provide training to personnel involved in the operation, maintenance, and monitoring of the air filtration system.
2. Ensure personnel are aware of SOP updates and revisions related to the air filtration system.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

1. Air filtration system maintenance log
2. Filter replacement schedule
3. Validation reports

7) Reference, if any

GMP Guidelines for Pharmaceutical Manufacturing

8) SOP Version

Version 1.0